Prosthesis adapted for placement under external imaging

ABSTRACT

A expandable prosthesis having an imageable structure comprising one or more elements visually distinguishable by an external (e.g., radiographic or ultrasonic) imaging system, the structure being located about a first axis that corresponds to a structural feature of the prosthesis that is configured to perform a specific function particular to that axis. The imageable structure is configured to assist in the rotational orientation of the prosthesis during placement within the implantation site. In one embodiment, the prosthesis comprises a venous valve that includes imageable elements or structure, such as a pair of radiopaque markers, that defines the orifice of the valve structure such that the orifice can be oriented with a particular anatomical feature under imaging, such as to align the orifice with the long axis of the vessel. In another embodiment, the imageable structure is configured to permit an aperture located about a stent graft to be oriented with a anatomical feature of the vessel, such as a branch vessel opening. The invention includes a method for using imageable structure to confirm that the orientation of the prosthesis within a delivery apparatus is consistent the desired delivery approach to be used.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority of U.S. Provisional Application Ser.No. 60/450,396, filed Feb. 26, 2003.

TECHNICAL FIELD

This invention relates to medical devices, more particularly tointraluminal prosthesis, such as valves, stents, and the like, placedusing external imaging methods.

BACKGROUND OF THE INVENTION

Prosthetic or artificial valves have been developed for placement in thevenous system to augment or replace native valves whose functionalityhas been compromised. Valves become incompetent when the cusps cannotclose sufficiently to prevent reflux of blood, thereby causing it topool in the lower extremities which often leads to painful swelling ofthe lower legs and feet.

Based on the initial animal and clinical experience with the placementof prosthetic venous valves to treat chronic venous insufficiency in thelower extremities, some physicians feel that placement strategies playan important role in the efficacy of the treatment. One strategy is toplace the prosthetic valve near or across the native valve to takeadvantage of what functionality may still exist and/or derive theoptimal physiological location. The deep veins of the legs typicallyhave a elliptical cross-sectional shape due to compression by theadjacent muscles that lie on either side of the vessel. It is the actionof these muscles against the vessel that help to propel the blood towardthe heart. During investigational animal studies of our own earlyprototype venous valves, efforts were under to orient the orifice withthe long axis of the vessel in the expectation that such an orientationwould improve functionality of the valve. This proved difficult toaccomplish under fluoroscopy since that the leaflet structure andsupport structure of a typical artificial valve offers little or novisual guidance to aid in aligning the orifice accordingly. While goldor other radiopaque markers have been used to identify the ends ofcoronary and other types of stents to aid in longitudinal positioningacross a stricture, lesion, or other target site (e.g., U.S. Pat. No.6,409,752), the need for circumferential orientation has generally notbeen addressed and thus, previous marker arrangements have not beendesigned to be particularly useful for that purpose. Needless to say, ifa specific orientation of the prosthesis is critical, it must beaccomplished prior to deployment, particularly if the prosthesis isself-fixating, such as by virtue of barbs or other anchoring structure.

What is needed is a prosthesis having a preferred circumferentialorientation within the vessel that includes structure or some means bywhich the clinician can readily ascertain under fluoroscopy or someother imaging system, whether the prosthesis is correctly rotated withinthe vessel prior to deployment.

SUMMARY OF THE INVENTION

The foregoing problems are solved and a technical advance is achieved inan illustrative prosthesis placeable into a body lumen and whichcomprises a support structure configured to engage the walls of the bodylumen, the prosthesis having a cross-sectional profile that includes afirst axis traversing at least one structural feature or characteristicof the prosthesis adapted and configured to provide a specializedfunction particular to the first axis or a location therealong, thatfunction be separate from that of the remainder of the supportstructure, which typically is to engage the walls of the bodily, anchorthe prosthesis, and/or maintain a patent passageway. The first axistransects the passageway of the prosthesis support structure withstructural feature lying either across the axis or at one or more pointalong the axis, such as along the periphery of the prosthesis. Theprosthesis further includes one or more imageable element, such asradiopaque markers, located about the first axis that are configured toallow one to identify the orientation of the first axis relative to ananatomical feature of the body lumen while the prosthesis is beingplaced using external imaging guidance. For purposes of thisapplication, terms ‘radiopaque markers’ and ‘radiopaque material’ areunderstood to mean any element or structure comprising or consisting ofa high-density material (e.g., gold, platinum, tantalum, tungsten,barium, bismuth, etc.) in a sufficient quantity that the marker isreadily visible and distinguishable from adjacent structure underradiographic (fluoroscopic or x-ray) imaging.

In one aspect of the invention, the prosthesis comprises an artificialvalve that opens and closes in response to fluid flowing therethroughand changes in the pressure differentials on either side of the valve.The artificial valve includes a plurality of leaflets, such as a pair ofopposing leaflets, that define an orifice therethrough. In oneembodiment, the two imageable elements comprise a first radiopaquemember located about the first end of the orifice and a secondradiopaque member located about the second end of the orifice (i.e., theouter edges of leaflets defining the orifice) such that under externalfluoroscopic imaging, the operator can determine the orientation of thevalve within the vessel. The radiopaque markers allow rotationalpositioning to align the valve with a feature of the vessel, such as atthe long axis thereof or the native valve lying adjacent to where thevalve is placed. The radiopaque markers can comprise beads of gold orsome other radiopaque material that are inserted into the coiled bendsand secured by flattening and enlarging the ends so that the bead cannotfall out and/or by securing the bead within a fold of the coveringmaterial that is sutured or otherwise attached to the framework of theprosthesis.

In another aspect of the invention, the radiopaque markers are attachedto a strut of the framework at strategic locations, such as forpermitting identification of the valve orifice. Embodiments include, butare not limited to, pressing or securing a radiopaque metal bead into anaperture formed in the framework (such as one formed when a frame islaser cut from a metal tube); wrapping radiopaque metal wire around thestruts; attaching and/or crimping radiopaque metal cannulae over thestruts; and applying an outer layer of radiopaque material to theframework, such as by dipping the struts in molten gold or coating witha polymer loaded with a radiopaque filler material.

In yet another aspect of the present invention, selected portions of theframe, such as struts, barbs, etc., are made from a radiopaque material.These elements are aligned with a structural feature of the prosthesis,such as the valve orifice, so that the clinician can ascertain theposition of the prosthesis under radiographic imaging.

In still yet another aspect of the present invention, the supportstructure is configured in a manner that permits identification ofparticular areas that correspond to a feature of particular importanceon the prosthesis. Embodiments include altering the shape, length, ornumber of struts in a particular location along the circumference of thesupport structure to provide an imageable marker that is visible underfluoroscopic guidance or some other method of imaging.

In still yet another aspect of the present invention, the imageablestructure comprises an ultrasonically reflective surface, such asproviding a series of indentations in the surface of the supportstructure that are configured to reflect sound waves and allow forultrasound imaging of that particular region. As with theradiographically imageable structure, the ultrasonically reflectivesurface would be located at selected points along the prosthesis thatcorrespond with a particular critical feature or structure thereof.

In still yet another aspect of the present invention, the imageablestructure comprises radiopaque elements that are positioned around anaperture formed through the material that covers a prosthesis, such as astent graft, so that under radiographic guidance, the aperture can bealigned with a structure such as the opening to a branch vessel or duct.

In still yet another aspect of the invention, imageable markers areplaced in strategic locations for allowing the clinician to determine ifthe prosthesis has been deployed correctly or is otherwise functioningproperly. One embodiment includes placing radiopaque markers at selectedlocations that would indicate if the prosthesis becomes tilted at orfollowing deployment. In another embodiment, the leaflets of aprosthetic valve can include radiopaque or imageable markers ormaterials that would allow the clinician to determine whether the valveleaflets are opening and closing to effectively regulate blood flowtherethrough.

In still another aspect of the invention, imageable markers are used toensure that the orientation of the orifice of a valve or other structurefeature whose longitudinal orientation (proximal or distal within thevessel or bodily lumen) is critical for the function of that particulardevice. Radiopaque markers or other imageable structure placed about theprosthesis for rotational alignment of the prosthesis may also beadapted for use in proper loading and orientation of the prosthesiswithin the delivery apparatus. This is of particular importance in avalve prosthesis in which the location and orientation of the valveorifice is important in the functionality of the valve after deployment.Typically, the leaf structure of a vascular valve is configured to allowunidirectional flow such that retrograde flow will cause the valve toclose. Thus, if the valve is placed backwards or upside down within thevessel, it becomes an occluder device and in the venous system, ratherthan a valve, will not permit normal antegrade blood flow back to theheart. As such, it is especially critical that when loading a venousvalve into a delivery apparatus, that verification of the correctlongitudinal orientation of orifice occurs before the device is usedclinically. This can be done by examining the device (delivery apparatusand loaded valve) under fluoroscopy or other appropriate imaging systembefore the product leaves the manufacturer or at least before it is usedwithin the patient, to ascertain that the radiopaque marker or otherimageable structure is oriented correctly to ensure correct function ofthe valve after deployment.

Radiographic verification is not only important to prevent errors duringthe loading process, but because the longitudinal orientation of thevalve within the delivery apparatus is different depending on whetherthe delivery approach is ascending (with the delivery catheter coming upfrom below the implantation site, such as via the femoral vein) ordescending, (an approach via a vein above the implantation site, such asthe jugular or subclavian veins). In a typical venous valve, the orificeor inner edges of the leaf structure is located at the proximal end(toward the head) so that the leaflets slope at least slightly downwardand away, thus being configured to catch blood and close the valve. Inthe illustrative example of the present invention, the orifice isconfigured and oriented toward the first or a delivery apparatusintended for an ascending approach, the orifice is generally configuredand oriented toward the first or proximal end of the prosthesis. One ormore radiopaque markers located at the proximal end allow the clinicianto determine that the orifice is oriented toward the distal tip of thedelivery apparatus and thus, the delivery apparatus is configured for anascending approach. For a descending approach, the orifice andassociated imageable markers are located at the end of the valvefurthest from the distal tip of the delivery apparatus such that whenthe delivery system is oriented downward with the tip toward theimplantation site, the valve will be in its proper orientation.

Preferably, the delivery apparatus valve prosthesis, package, labeling,or instructional materials located within the outer package (the latterthree comprising the ‘packaging material’) include some type of specificindicia or warning or other identification that allows one to determinewhether the system is intended for an ascending or descending approach.The imageable structure, preferably located about the orifice at one endof the device, provides further providing confirmation of theorientation of the valve within the delivery apparatus. Besides used forrotational orientation, and confirmation of proper longitudinalorientation, the imageable structure can be used for more preciselyplacing the orifice in the proper located in the vessel longitudinally.

In another embodiment, the valve prosthesis can be loaded just prior touse in a delivery apparatus configured for either an ascending ordescending approach, such as by having the valve preloaded in a loadingmember, such as a cartridge other constraining element, that isinsertable into the passageway of the delivery apparatus and whichincludes separate indicia or instructions for loading orientationdepending on whether an ascending or descending approach is to be used.The indicia for facilitating proper orientation and loading of the valveinto the delivery apparatus can be imageable, such as a radiopaquemarker on the valve or radiopaque marker or band around a particular endof the loading cartridge, or it may include other types of externalindicia (lettering, color(s), variable shapes, etc.) that allow one todetermine the orientation of the valve during loading for a particulardelivery approach. For purposes of defining the scope of the invention,the loading element is considered part of the prosthesis in determiningthe presence or location of imageable structure on the prosthesisrelative the orifice or other structural feature while the prosthesis(and loading element) is inside the delivery apparatus.

BRIEF DESCRIPTION OF THE DRAWING

Embodiments of the present invention will now be described by way ofexample with reference to the accompanying drawings, in which:

FIG. 1 depicts a perspective view of an artificial venous valve of thepresent invention;

FIG. 1A depicts a detailed view taken from FIG. 1;

FIGS. 2-4 depict the steps of placing and securing the radiopaque markerof the embodiment of FIG. 1 into a prosthesis having a covering;

FIG. 5 depicts the placement of an embodiment of radiopaque marker intoa prosthesis of the present invention having a covering;

FIG. 6 depicts a side view of an embodiment of an illustrativeradiopaque marker that is embedded within the support structure;

FIG. 7 depicts a side view of an embodiment of an illustrative imageablestructure that comprises a thick layer of radiopaque material;

FIG. 8 depicts a side view of an embodiment of an illustrativeradiopaque marker comprising thin radiopaque wire wrapped around thesupport structure;

FIG. 9 depicts a perspective view of the support structure of theembodiment of FIG. 1;

FIG. 10 depicts a partially sectioned view of the support structure ofFIG. 9 compressed within a delivery catheter;

FIGS. 11-12 depict a side view of an embodiment of the present inventionin which a portion of the support structure comprises a distinctiveradiographic profile;

FIG. 13 depicts a side view of an embodiment of the present invention inwhich the support structure includes an ultrasonically reflectivesurface;

FIGS. 14-15 depict perspective views of covered stent embodiments of theinvention which include a side aperture with radiopaque markers

FIG. 16 depicts a perspective view of an embodiment of the presentinvention in which the leaflets each include a radiopaque marker.

FIGS. 17-18 depict side views of the valve of FIG. 16 in the open andclosed position;

FIG. 19 depicts a side view of an embodiment of the present inventionthat includes additional radiopaque markers to indicate whether theprosthesis has tilted at or following deployment;

FIG. 20 depicts a partially sectioned view of a valve being placed usinga ascending approach;

FIG. 21 depicts a partially sectioned view of a valve being placed usingan descending approach;

FIG. 22 depicts a partially sectioned view of a valve in a loadingcartridge for insertion into a delivery apparatus; and

FIG. 23 depicts a method of determining the orientation of the valveprior to use within an patient; and

FIG. 24 depicts a top view of a prosthesis of the present invention inwhich the structural feature comprises a long axis of anelliptical-shaped passageway.

DETAILED DESCRIPTION

As embodied in FIGS. 1-23, the present invention is exemplified by anintraluminal prosthesis, typically of a generally tubular or cylindricalshape (cylindrical being defined to include flared or variable-diameterconfigurations), such as a expandable or self-expanding artificial valve10, stent, stent graft, occluder, shunt, filter, or the like, thatfurther comprises elements or structure that allows a clinician, using aselected means of external guidance, such as fluoroscopy, X-ray,ultrasound, M.R.I., etc., to readily identify the plane in which theprosthesis, or a particular portion thereof, lies prior to deploymentwithin the patient and/or immediately thereafter. For example, toidentify a structural feature 24,82, etc., disposed about a first axis97 transecting the passageway 96 of the prosthesis, the imageablestructure the imageable structure 12 or element is configured orpositioned about the axis 97 to allow the clinician to adjust theposition of the prosthesis (e.g., by rotation) within the bodily lumensuch that the structural feature of the prosthesis, such as an orifice24, aperture, port, specialized anchoring element (whose orientation isparticularly critical), covering, leaflet, or other difficult-to-discernstructure that has a separate function that the general supportstructure. The external imaging guidance system allows the clinician toorient or locate the structure feature relative to the supportstructure. By ascertaining the rotational orientation of the first axis97, the structural feature can be aligned to a particular orientation orfeature of the patient's anatomy so that the prosthesis will function ina desired or preferred manner. Examples of a particular feature of thepatient's anatomy to which the orientation of a prosthesis could bemanipulated would include the shape of a vessel or duct, such as itscross-sectional shape (e.g., elliptical), a particular bend or contour;a branch or shunt of a vessel or duct; a valve, sphincter, organ, gland,or other native structure; a stenosis or stricture, or any otheranatomical feature that would affect how the prosthesis is placed withinthe vessel or duct. For definition purposes, the prosthesis of thepresent invention comprises a general structure or configuration thatwould not ordinarily include imageable features related to its primaryfunction that would otherwise allow reliable identification of itsorientation under external imaging without the incorporation of thesupplemental imageable structure or elements of the present inventionthat correspond to a functional characteristic of the device. It isacknowledged that most prosthetic devices include a frame or structurethat is at least somewhat visible under at least one external imagingmethod, such as fluoroscopy, ultrasonograhpy, etc. However, only asubset of these prosthetic devices includes a structural adaptation forenhancing the ability of the device to be placed using external imaging,and typically such structural elements are limited to those, such asradiopaque markers at one or more ends of the device for facilitatingplacement at a target location, and do not correspond with a structuraladaption of the device for performing any particular function. The scopethat includes prostheses having a specific orientation corresponding toan anatomical feature of the patent (but lacking useful inherentstructural features that are imageable) would specifically excludeprosthetic devices that are bifurcated (such as a stent graft forexcluding aneurysms), have imageable side branches, or comprise aspecific imageable shape is associated with the primary function of thedevice and that also permits ready identification of rotational or otherorientation without requiring supplemental imageable structure adaptedfor providing such identification. Examples of prosthetic devicesincluded in the scope of the invention include, coronary and other basictubular stents or stent grafts, artificial valves, occlusive devices,shunts, and other prostheses whose support structure lacks a distinctiveprofile to allow identification of whether the prosthesis has attainedthe critical or desired orientation or position within the patient.

FIGS. 1-1 a depict a first embodiment of the present inventioncomprising a prosthetic valve 11, such as the illustrative artificialvenous valve used to augment or replace the function of a patient'sincompetent native valve, typically located within the deep veins of thelegs, whose function has been compromised due to disease or age-relatedfactors. The illustrative valve 11 includes a leaf structure 16, such asa covering 36 comprising a pair of leaflets 17 attached to a first andsecond leg 30,31 that comprise a portion of the support structure 15 orframe of the prosthesis 10. The illustrative leaflets 17 are attached tostruts of the frame 15 by folding the covering 36 over itself and theframe and securing it with a series of sutures or some other suitablemethod, such as adhesives, laser tissue welding, etc. The imageablestructure 12 of the present invention comprises a first and a secondimageable element or marker 13,14, such as the illustrative goldradiopaque members 39, which are located about each end of the elongateorifice 24 of the valve (the first and second ends of the orifice beinggenerally coincident with bends 43 and 44 in the illustrative example),the orifice being defined by either a slit formed within the leafstructure 16 or the opening adjacent to and between the inner edges 73of the opposing leaflets 17.The arrangement of the two markers 13,14allows the physician, under fluoroscopic guidance, to determine theorientation of the orifice by the location of the markers 13,14 relativeto one another as they appear on the viewing monitor. In the exemplaryblood vessel 25, there is a long axis 28 of the cross-sectional vein,lying generally parallel with the muscles compressing the outer wallsthereof (not pictured), and a short axis 29 perpendicular to the longaxis. Typically, but not always, the cusps of the native valve, areoriented such that the natural orifice lies along the long axis 97.Thus, if the prosthetic valve 11 is to be placed to align the leaflets17 and orifice 24 with the native valve cusps (not pictured), theradiologist or clinician can rely on the radiopaque members 39comprising the first and second markers 13,14 to determine if theprosthetic valve orifice is aligned with the long axis 28 of the vessel(assuming the viewing angle is perpendicular to the long axis 28). Thiswould be the case if the markers 13,14 appear at the right and leftedges of opposite inner walls 26 of the vessel 25 and have the maximumavailable spacing therebetween. Conversely, if the markers 13, 14 aregenerally superimposed over one another within the same viewing angle,it would indicate that the general alignment is with the short axis 29.By rotating the delivery catheter or system prior to deployment, thephysician can correctly align the prosthetic valve 11 with the long axis28. Preferably, this is performed while the prosthesis 10 is in thecompressed state 75, such as depicted in FIG. 10, which shows thesupport structure 15 (lacking a leaf structure) compressed within adelivery member 59, such as an introducer catheter. While the purpose ofFIG. 10 is to illustrate a variety of embodiments of imageable structureof the present invention, it can serve to illustrate how a prostheticvalve would appear under fluoroscopic imaging when the orifice 24(FIG. 1) is perpendicular to the viewing angle, assuming that bends 43and 44 represent the respective imageable radiopaque markers (notactually shown), such that they appear as two distinct members locatedalong the inner walls 74 of the delivery member 59. If the prosthesis 10were to be rotated 90°, the radiopaque marker would appear as a singlepoint located midway within the delivery member 59. Thus, as long as theplane of the long axis 28 of the vessel is known, the prosthesis 10 canbe aligned using the imageable structure 12 for orientation.

FIGS. 1-2 depict a first embodiment of imageable structure 12 comprisinga radiopaque member 39, such as a bead comprising gold, platinum,tantalum, tungsten, or some other radiopaque material, that is insertedand secured within a coiled bend 18 of the support structure. Theillustrative radiopaque member 39 includes an intermediate or centralportion 42 having an outer diameter that is less than the inner diameterof the coiled bend 18, such that there is sufficient room or ‘play’ thatthe radiopaque member 39 does not interfere with the function of thecoiled bend 18 when flexing occurs. The first end portion 40 comprises alarger diameter than the inner coil 18 diameter to help maintain theradiopaque marker 39 in place. FIG. 2 depicts a method of securing theradiopaque marker 39 in which the second end portion 41 is formedsmaller than the inner coil 18 diameter so that it may be insertedthrough the coiled bend 18. Afterward, force is applied against thesecond end portion 41 using a suitable instrument or means to deform themetal of the second end 41 and increase its diameter (FIG. 1 a) suchthat the radiopaque member 39 is secure at both ends and cannot fall outof the passageway defined by the coiled bend 18.

Additional prevention against the radiopaque member 39 becomingseparated from the support structure 15 can be attained by enclosing orsealing the coiled bend 18 and radiopaque member 39 together, such asthe method depicted in FIGS. 3-4. The excess or overhang 37 of thecovering 36 made of a biomaterial (such as small intestinal submucosa oranother extracellular collagen matrix) or woven material comprising theleaflet 17 is folded over the bend 18 and adjacent struts 20,21 of thesupport structure 15 (FIG. 3) and secured with sutures 38 or some othermethod of sealing or joining the covering 36 (FIG. 4), therebycompletely enclosing the radiopaque member 39 in a pocket. As depictedin FIG. 5, the same method can be used to enclose a spherical bead 76 orother radiopaque element 39 which lacks a specific structuralmodification, such as the enlarged end portions 40,41 of FIG. 1A, tohold the bead within the coiled bend 18 unless sealed therein by anothermeans. Alternatively, the bead or radiopaque marker 39 can be insertedunder the fold 37 (overhang) of the fabric at a location outside of thebend and secured therein.

Alternative embodiments of radiopaque members 39 or structure may bebetter adapted for use in a particular type of intraluminal prostheses,especially those lacking coiled bends. FIG. 6 depicts a radiopaquemember 39, such as a small gold bead, that has been pressed into anaperture formed within a strut at or near the bend 43 of the supportstructure 15 of a prosthesis. The radiopaque member 39 is preferablyground down or polished until it is flush with the surface of thesupport structure. The marker is preferably tapered to help lock themarker within the aperture to prevent it from becoming dislodged. Aswith the embodiment of FIG. 1, the imbedded radiopaque member 39 canrepresent one of a pair, each located on either side of an orifice of avalve. Alternatively, the radiopaque member 39 itself can be formed intoa distinctive shape, such as a ‘T’, such that it has a differentradiographic profile in one plane as opposed to another, thusidentifying a particular orientation. Preferably, such a distinctiveshape would need to be sufficiently large to be easily imageable, thesize being determined by the type and resolution of the imaging systemselected. Various configurations and methods for affixing the radiopaquemaker into the aperture are described in U.S. Pat. No. 6,464,720 toBoatman et al., the disclosure of which is expressly incorporated byreference into this application.

FIGS. 7-8 depict alternative methods of adding materials to the supportstructure 15 to create a radiopaque marker 39 at a particular bend 18.In the illustrative embodiment of FIG. 7, the struts 20,21 (and apex ofthe bend 43) include a layer 46 of radiopaque material which is appliedor deposited in one of any well-known manners appropriate for thatparticular material, including dipping, electrostatic deposition,spraying, painting, overlaying, wrapping, etc. One example of adding alayer 46 of radiopaque material is to dip the bend 43 in molten gold.Optionally, a protective polymer overcoat may applied as well to preventflaking and degradation of the thin layer 46 of outer material.Furthermore, a polymer resin coating could be substituted that includesradiopaque filler material such as barium sulfate, bismuth, or tungstenpowder. FIG. 8 depicts an alternative embodiment comprising a pair ofimageable elements 13,14 made of radiopaque wire 77 or thread (i.e.,gold, platinum, titanium, etc.) that is wrapped around the struts 20,21to form a radiopaque member 39. The radiopaque members of FIGS. 7-8 canbe used to mark a single bend or used in combination to define a valveorifice as opposing imageable elements 13,14 at opposite bends.

As an alternative to adding one or more radiopaque members 39 to thesupport structure 15 for orienting the prosthesis 10, one or componentsof the support structure 15 itself can be made of radiopaque metal orother material that would permit orientation of the prosthesis underfluoroscopic or x-ray guidance. FIGS. 9-10 depict the support structure15 of the exemplary venous valve depicted in FIG. 1 comprising a numberof components that are interconnected by a series of cannulae51,52,53,54,55,56,62,63. In an example of using the support structure 15as imageable structure 12, one of more of the cannulae 51,62 at thefirst bend 43 and one or more cannulae 55,80 at the second, oppositebend 44 can comprise a radiopaque material to permit orientation of theorifice 24 therebetween. FIG. 10 depicts the embodiment of FIG. 9 in acompressed state 75 whereby the at least two of cannulae 51,55,62 and 63would be visible, if made sufficiently radiopaque, thereby allowing theradiologist to determine that the orifice 24 was generally perpendicularto his or her plane of view 67 (see FIG. 9), particularly if theprosthesis is rotated such that the radiopaque cannula or cannulaemarking at each of the first and second bends 43,44 are the maximumdistance apart from one another. If rotated 90° to a second plane ofview, any radiopaque cannula 51,55, or 61,63 would be superimposed overone another so that they would appear as a single radiopaque element 39located midway within the prosthesis 10 and delivery catheter 59.Obviously, two closely-spaced radiopaque markers would indicate that theorifice 24 was oriented somewhere between planes 67 and 68 relative tothe viewer. Alternatively, both radiopaque cannulae can be placed at asingle bend 18, rather than opposites bends 43,44 (e.g., cannula 51 andcannula 62). Depending on the ability of the imaging system to allow theoperator to discern two close, but separate radiopaque markers 39, theplane of the orifice 24 can be determined, For example, when a singlevisible radiopaque element 39 is visible under imaging, it generallyindicates that the orifice 24 is lying in a plane perpendicular to theviewer.

The basic method for placing a valve 11 in a vessel or vein 25 isdepicted in FIG. 20. Using an external imaging unit or system 91, suchas the illustrative fluorosope, a radiographic beam 92 allows theclinician to visualize the delivery system 86 on a monitor as it isadvanced to the implantation site 95 following its introduction via avenous puncture (not shown) which in the illustrative example, is madeinto a vein at a site located below the implantation site 95 so that thedelivery apparatus 86 is withdrawn distally (toward the feet) afterdeployment. At the implantation site 95, the clinician determines thelocation of the imageable marker, which in the figure, comprises aradiopaque marker 39 generally aligned in lateral profile with locationof the orifice 24 of the leaf structure 16 (preferably a pair ofopposing radiopaque marker 13,14 disposed about opposite ends or bends43,44 of the orifice as depicted in FIG. 1). The clinician uses theradiopaque marker 39 to longitudinally align the valve 11 at thedeployment site, such as using the method described above for FIGS. 7-8.Optionally, he or she may rotationally orient the valve, such as toalign the orifice 24 or other structural feature of the prosthesis 10with a particular anatomical feature of the implantation site 95 (e.g.,the long 28 or short 29 axis of the vessel 25). The clinician rotatesthe delivery system 86 within the vessel 25 to orient the first axis 97transecting the imageable structure 12 (radiopaque marker(s) 39) andstructural feature or orifice 24 of the prosthesis until the imageablestructure/structural feature and the desired anatomical feature aregenerally in alignment within the desired plane that allows confirmationof alignment (typically in alignment with or perpendicular to the planeof view provided by the imaging beam. Preferably, the anatomicalfeature, such as the illustrative long axis of the vessel 28 is eitherdirectly aligned with the plane of view or is perpendicular thereto tofacilitate correct placement of the prosthesis and eliminate a potentialsources of confusion during the alignment process. The outerconstraining member 59 or delivery catheter is withdrawn, deploying theself-expanding valve 11 (which typically comprises a nitinol orstainless steel support structure) such that the valve is anchored atthe site 95 and is able to function in manner similar to a competentnative venous valve to restrict retrograde flow. The inner member 85over which the valve was mounted is then withdrawn through the expandedvalve and removed via the original venous puncture site.

Again referring to FIGS. 9-10, the cannulae comprising radiopaquemarkers 39 can be distributed in other ways that would facilitatefluoroscopic orientation of the prosthesis 10. For example, thosecannulae located toward the second or distal end 79 of the valve (e.g.,cannulae 54 and 58 and/or 53 and 57), if radiopaque, would indicate thatthe orifice 24 was lying perpendicular to the viewing plane if centeredwithin the prosthesis 10 as it is imaged. These cannulae 53,54,57,58 canbe used in combination with selected ones at the first or proximal endof the prosthesis 78 to form a pattern of radiopaque markers 39 thatindicate the rotational orientation of the device 10.

As an alternative to making the cannulae radiopaque, other portions ofthe support structure 12 can comprise radiopaque material, such as thebarbs, struts, bends or sections comprising a combination thereof. Inthe embodiment of FIG. 9, barb struts 22,60 can be made of radiopaquematerials such that if the orifice is perpendicular to viewing angle 67,they converge toward the second end 79 of the prosthesis 10. Conversely,if rotated 90° counter-clockwise, barbs 22 and 61 (assuming they areboth radiopaque) would also appear as a V-shaped radiographic image, butwith the anchoring barb portions 23 converging toward the first orproximal end 78 of the prosthesis 10.

Again referring to FIG. 9, other portions of the frame, such as one ofmore of the lateral arms or bend 32,33,34,35 of the illustrativeprosthesis, can be made of radiopaque material to create a uniqueprofile for identifying the orientation of the device. In theillustrative embodiment, these radiopaque sections 32,33,34,35 wouldappear W-shaped under fluoroscopy when oriented generally perpendicularto a given viewing angle.

As an alternative to the use of radiopaque elements as markers toindicate orientation of the device, the imageable structure 12 cancomprise a support structure 15 in which a portion or region thereofcomprises a visually distinctive imageable structure 12, such asparticular shapes or additional elements that offer a unique profileunder imaging, examples of which are depicted in FIGS. 11-12. As withradiopaque elements or markers, the location of the imageable structure12 provides a visual identification cue to a structural feature of thedevice, such as a valve orifice, side opening, anchoring means, etc.,the location of which on the prosthesis would need to be known by theclinician. The support structure 12 of the present invention wouldcomprise materials or a configuration that is capable of producing asufficient radiographic or other type of image that would permit theclinician to discern or recognize the portion of the prosthesis havingdistinctive imageable structure 12 critical for the identification ofthe feature of interest.

In the embodiment of FIG. 11, the imageable structure 12 comprises aplurality of enlarged areas 64 along the struts 20,21 that provide adistinct profile under imaging. This allows for the identification ofthe adjacent interconnecting bend 43 as having significance to thedesired orientation of the device 10, such as to mark two opposite bends43,44 as in the embodiment of FIG. 1. Similarly, imageable structure 12can be added to the bend 43 by adding a supplemental strut 70, such asdepicted in the embodiment of FIG. 12, in which an extra V-shape strut70 extends from struts 20 and 21 adjacent to bend 43. By restrictingsuch a supplemental strut 18 to any bend or region which could be usedto identify the preferred orientation of the prosthesis in the mannerpreviously discussed. The examples in FIGS. 11-12 are merely exemplaryand one skilled in the art could readily conceive of other structuraladaptations that would provide a distinctive imageable profile, whilepossibly offering certain structural advantages as well.

While intraluminal prostheses are most commonly placed with the aid offluoroscopy or x-ray, other methods of imaging can prove useful ornecessary in some clinical situations. FIG. 13 depicts a bend 43 inwhich the imageable structure 12 comprises an ultrasonically reflectivesurface 71 comprising a plurality of indentations 72 of a particulardensity and configuration for enhancing the imageability of thatparticular area of the prosthesis. The illustrative ultrasonicallyreflective surface 71 is described in U.S. Pat. No. 5,081,997 to Bosley,with the disclosure thereof being expressly incorporated by referenceinto this application. As with the radiographic markers previouslydiscussed, the ultrasonically reflective surfaces 71 can identify keypoints along the prosthesis that provide the same assistance in allowingthe clinician to orient the prosthesis to optimize its function.

The imageable structure 12 of the present invention can be utilized toidentify other structural features of the prosthesis 10 that provide aparticular function or clinical advantage. FIG. 14 depicts a coveredstent 80 with an aperture 82 in the covering material 81, such as onethat would allow alignment with the opening to a branch vessel or duct.The aperture 81 may exist at only one location along the circumferenceof the stent, or there may be oppositely placed apertures aligned alongan axis, such as to accommodate both right and left branch vessels. Topermit identification of the aperture under fluoroscopy, the aperture isbordered by a series of radiopaque markers 39, which in the illustrativeembodiment, comprise radiopaque wire 77 or thread that is wrapped aroundthe struts of the support structure 15 to form a ‘box’ that surroundsand generally corresponds to the outer border of the aperture 82. Theradiopaque wire 77 can either by wrapped around the struts only, or itcan be threaded through the material to bind the support structure 15 tothe material 81. In another embodiment depicted in FIG. 15, theimageable structure 12 comprises a radiopaque marker 39, such as theillustrative radiopaque thread 77, that rings the edges 83 of theaperture 82 within the covering material 81 of a stent graft 80 of otherprosthesis to provide precise identification of the extent of theaperture 82. The radiopaque thread 77 can either be stitched by hand ormachine-stitched with a suitable sewing or suturing device. Theradiopaque wire or thread 77 depicted in FIGS. 14-15 is merely exemplaryof the various types of radiopaque markers 39 and other imageablestructure 12 that can be used or configured to identify the aperture 82or another feature, such as a slit, port, bifurcation, etc.

FIG. 24 depicts another embodiment of the present invention in which thestructural feature of the prosthesis 10 comprises passageway 86 having alonger first diameter 98 measured along the first axis 97 than a secondpassageway diameter 99 located about the second axis 100 locatedperpendicular to the first axis such that the passageway, as viewed fromabove, is of an elliptical shape, such as to better conform with anelliptically shaped vessel. For example, the support frame 15 of such aprosthesis 10 can be formed of an elliptical shape with prosthesiscomprising a valve with an orifice lying along the long first axis 97such that the structural feature comprises both the first passagewaydiameter 98 and the orifice (not shown in this example). The imageablestructure 12 of the illustrative example comprises a first and secondradiopaque marker 13,14 located at the first and second bends 43,44located along the long passageway diameter 98 and thus, the first axis97. It is certainly within the scope of this invention that theimageable structure 12 be located about the short passageway diameter 99such that the short diameter becomes the main structural feature ofinterest and thus, the first axis 97 is coincident with the shorterpassageway diameter 99. A valve orifice, if present, would become asecondary structural feature (such as 101 in FIG. 16) that does not lieon the first axis that includes the imageable structure 12, beingdisposed instead on a second axis 100 perpendicular to the first axis97. Referring now to the example of FIG. 16, the second axis 100optionally may include secondary imageable structure 102, such asradiopaque markers (not shown) at bends 43 and 44, that identifies thesecondary structural feature 101 (orifice 24 in this example), althoughit is preferred that the secondary imageable structure 102 beingvisually distinguishable from the first imageable structure 12 underexternal imaging so that the relative orientation of the structuralfeature (long diameter 98 in FIG. 24, leaflet inner edges 73 in FIG. 16)and the secondary structural feature (the valve orifice 24) can bedetermined radiographically or by some other appropriate imaging means.

FIGS. 16-18 depict an artificial valve prosthesis 11 of the presentinvention in which the imageable structure 12, consisting of a pair ofradiopaque markers 39, is placed on the leaflets 17 so that underimaging, the clinician can determine if the leaf structure 17 isfunctioning (coapting) to regulate blood flow and prevent excessivereflux back through the valve. In the embodiment depicted in FIG. 16, afirst and a second 13,14 radiopaque element are placed on opposingleaflet 17, by attaching the radiopaque elements 13,14, which compriseradiopaque thread 77 (gold, platinum, etc.) in the illustrativeembodiment, about the inner edges 73 of the leaflets 17(either at ornear the leaflet edges) such that the markers 13,14 are able to come inclose proximity to one another when the valve 11 is deployed in a vessel25 and is in the closed or coapted position 86 due to retrograde flow 84closing the valve, as shown in FIG. 17. As the leaflets 17 move into theopen position 87 in response to normal antegrade blood flow 85 towardthe heart, the radiopaque elements 13,14 move away from one another.This movement is detectable under fluoroscopic monitoring and would beindicative of a functioning valve 11. Conversely, if one or bothleaflets 17 were to adhere to the wall of the vessel 25 or would beimmobilized due to thrombus or some other reason, this should beapparent as well. If the radiopaque elements 13,14 do not appear to bemeeting one another when viewed under fluoroscopic monitoring, thiscould be indicative of an incompetent valve 11 that cannot sealsufficiently. The imageable structure 12 shown in FIGS. 16-18 is but onepossible embodiment. One skilled in the art would appreciate that thereare a wide variety of possible radiopaque elements and materials thatcan be attached to or adjacent the leaflets 17 or applied thereover tomake them at least partially visible under external imaging. Metallic orradiopaque polymer beads or disks can be attached to or through theleaflet service. Redundant leaflets or partial leaflets made of aradiopaque material can be placed in tandem with the primary leaflet 17so that movement of the primary leaflet can be detected. Radiopaqueparticulate or fluid materials can be incorporated into or bonded ontothe leaflet 17 to enhance radiopacity. The surface of the leaflets canalso be made ultrasonigraphically reflective. It also should be notedthat the first and second radiopaque elements 13,14 can be used togetherwith radiopaque markers placed on the opposing proximal bends 43,44 orelsewhere so that the orifice 24 can be visualized under imaging aswell.

In addition to placing radiopaque markers 39 on a valve prosthesis 11 atthe proximal bends 43,44 to define the orifice 24, or about the leaflets17 as a means of determining their functionality, imageable structure12, such as the illustrative first and second radiopaque markers 13,14placed at distal bends 88 and 89, can provide an indicator as to whetherthe valve 11 has tilted at or following deployment in the vessel 25, asdepicted in FIG. 19. If the path of the vessel 25 can be discernedradiographically, such as by the addition of contrast media, misalignedradiopaque elements 13,14 relative to the vessel path, as is the casewith those depicted in FIG. 19, would indicate that the valve 11 is notsituated correctly in the vessel 25 and thus, function of the leaflets17 may be compromised.

In addition to utilizing the imageable structure to determine therotational orientation of the structure feature (e.g., valve orifice),the functionality of the structural feature (e.g., leaf structure of avalve), or the longitudinal orientation of the valve (e.g., the presenceor absence of tilting), the imageable structure can be useful as anindicator that the prosthesis is oriented within the delivery apparatussuch that it will function properly depending on the method ofdeployment used. FIGS. 20-21 depict the two main methods of approachused to place a venous valve prosthesis at an implantation site 95within a vein 25, typically one of the deep veins of the lower legs(e.g., poplitea vein). FIG. 20 depicts an apparatus having a firstdelivery configuration 87 for an ascending approach where a venouspuncture (not shown) is made below the implantation site 95 and thedelivery apparatus 86 is advanced proximally (toward the heart and head)thereto. In the illustrative example, the valve 11 and orifice 24 aremounted on an inner member 84 and constrained inside a delivery sheath59 or constraining member (an example of a similar apparatus being morefully disclosed in U.S. patent application Publication No. 2003014467A1to Pavcnik et al. which is hereby incorporated by reference). The valve11 is oriented such that the leaf structure 16 at least partially slopesor extends downward away from the orifice 24 toward the second end 50 ofthe valve such that the leaflets are configured to catch retrogradeblood flow, thus causing the leaflets to coapt with one another and sealthe valve. In the example of FIG. 20, this results in the valve loadedsuch that orifice 23, first end of the valve 49, and accompanyingradiopaque markers 39 thereabout, are located closest to the distal end89 of the delivery apparatus 86 so that when deployed using an ascendingapproach, the valve is oriented in the vessel such that it can functionas intended. If the valve is accidently deployed upside down, the leafstructure 16 would likely not permit antegrade flow and thus, occludethe vessel.

FIG. 21 depicts an apparatus in a second delivery configuration 88 foran descending approach for valve placement in which the venous puncture(not shown) is made above the implantation site 95 (such as at thejugular or subclavian vein or groin) and the delivery apparatus 86advanced downward (toward the feet) thereto. The delivery apparatus 86and valve 11 arrangement differs from that of FIG. 20 in that theorifice 24, first end 49 of the valve, and radiopaque marker 39 areoriented oppositely, away from the distal end 89 of the deliveryapparatus 86, the second end of the valve 49 now lying closest to thedistal end 89 instead. This ensures correct deployment of the valve whenthe descending approach is used. Preferably, some type of indicia 90(markings, instructions, etc.) will be included on the deliveryapparatus 86 (as depicted), the valve prosthesis, or associatedpackaging material (e.g., outer/inner package, labeling, instructionalmaterial insert, etc.) that clearly identifies whether the valve 11 isloaded for an ascending or descending approach with the imageablestructure 12 (radiopaque markers 39) providing secondary confirmationthat the valve 11 is oriented for the delivery approach that isintended.

FIG. 23 depicts a method of ascertaining or confirming whether a valve11 preloaded inside a delivery apparatus 86 is in the first or secondconfiguration 87,88 delivery via an ascending or a descending approach,respectively. In the illustrative example, the valve 11 is orientedinside the delivery apparatus 86 in the ascending approach configuration87. An external imaging system 91, such as a fluoroscopy, x-ray,ultrasound, or M.R.I. machine, etc., emits a beam of energy 92 of theappropriate type so that an operator can view an image of the prosthesis10 (valve 11) loaded inside the delivery catheter to determine theorientation of the imageable structure 12 (radiopaque marker 39) whichis located about the first end 49 and therefore, in this example, shouldbe located closest to the distal end 89 of the delivery apparatus 86.These steps can be performed as a quality control step by themanufacturer before or after packaging, sterilization, or shipping toensure that the apparatus configuration 87 is consistent with indicia 90(permanent or temporary) placed on or to be place on the packagingmaterial 103 indicating that the prosthesis is to be placed using thedelivery approach (ascending) consistent with that particular deliveryconfiguration 87, or these steps can be performed in a clinical settingprior to introduction of the apparatus (valve 11 and delivery system 86)into the patient by a clinician. For example, even if indicia 90 clearlyidentify the proper delivery configuration 87,88, packaging material mayhave been removed at some point and thus, confirmation via externalimaging may provide additional assurance to the clinician that the valveis properly oriented for the approach selected. Another potentiallyproblematic situation is when the decision on which approach to usechanges, leading to potential confusion in associating the rightapparatus with the right procedure. To help eliminate such confusion, itis preferable to include clear markings or labeling located on thedelivery apparatus 86 itself to indicate the orientation of the valveand the proper direction or approach to be used with that particulardelivery configuration.

FIG. 22 depicts a valve prosthesis 10 that further comprises a loadingelement 93, such as constraining cartridge that is sized and configuredfor insertion into the passageway 104 of the constraining member 59 orcatheter of the delivery apparatus 86. The loading process can be donejust prior to the delivery process, thus allowing the same deliveryapparatus to be used, regardless of whether a ascending or descendingapproach is to be employed. The imageable structure may be located onthe valve 11, the loading element 93 or both to identify the location ofthe structural feature (orifice 24). The illustrative cartridge 93 aradiopaque band 94 that is generally aligned longitudinally with theradiopaque marker 39 located on the valve itself. The loading elementmay also comprise non-imageable indicia or structure to distinguish thedifferent ends 49,50 of the valve within and to identify the properorientation of the orifice 24.

Any other undisclosed or incidental details of the construction orcomposition of the various elements of the disclosed embodiment of thepresent invention are not believed to be critical to the achievement ofthe advantages of the present invention, so long as the elements possessthe attributes needed for them to perform as disclosed. The selection ofthese and other details of construction are believed to be well withinthe ability of one of even rudimentary skills in this area, in view ofthe present disclosure. Illustrative embodiments of the presentinvention have been described in considerable detail for the purpose ofdisclosing a practical, operative structure whereby the invention may bepracticed advantageously. The designs described herein are intended tobe exemplary only. The novel characteristics of the invention may beincorporated in other structural forms without departing from the spiritand scope of the invention. The invention encompasses embodiments bothcomprising and consisting of the elements described with reference tothe illustrative embodiments. Unless otherwise indicated, all ordinarywords and terms used herein shall take their customary meaning asdefined in The New Shorter Oxford English Dictionary, 1993 edition. Alltechnical terms shall take on their customary meaning as established bythe appropriate technical discipline utilized by those normally skilledin that particular art area. All medical terms shall take their meaningas defined by Stedman's Medical Dictionary, 27^(th) edition.

1. A method of verifying the orientation of a valve prosthesis within adelivery apparatus prior to introduction into a peripheral vessel of apatient, the valve prosthesis adapted for placement in the peripheralvessel, the valve prosthesis and delivery apparatus associated withpackaging material, the method comprising the steps of: providing thevalve prosthesis loaded within the delivery apparatus, the deliveryapparatus having a proximal end and a distal end adapted for insertioninto a body vessel of a patient, and the valve prosthesis having firstand second ends, a leaflet structure defining an orifice at the firstend and extending from the orifice toward the second end such that theleaflet structure is configured to catch retrograde blood flow, and animageable structure comprising first and second imageable elementslocated about the orifice, the valve prosthesis adapted for placement insaid peripheral vessel of said patient; imaging the delivery apparatusand the valve prosthesis prior to introduction into said peripheralvessel of said patient using an external imaging system to determine alocation of the imageable structure relative to the distal end of thedelivery apparatus; determining the orientation of the valve prosthesiswithin the delivery apparatus relative to the distal end of the deliveryapparatus using the determined location of the imageable structure; andverifying that the determined orientation of the valve prosthesis isindicative of a delivery approach specified by indicia located on atleast one of the delivery apparatus and the packaging material; whereina determined orientation in which the orifice of the valve prosthesis islocated closest to the distal end of the delivery apparatus such thatthe leaflet structure extends away from the orifice and away from thedistal end of the delivery device is indicative of an ascending deliveryapproach, and wherein a determined orientation in which the second endof the valve prosthesis is located closest to the distal end of thedelivery apparatus such that the leaflet structure extends away from theorifice and toward the distal end of the delivery device is indicativeof a descending delivery approach.
 2. The method of claim 1, whereineach of the first and second imageable elements comprises a radiopaquematerial.
 3. The method of claim 1, wherein each of the first and secondimageable elements comprises an ultrasonically reflective surface. 4.The method of claim 1, wherein at least one of the first and secondimageable elements defines a first shape when viewed in a first profileand a second shape when viewed in a second profile different from thefirst profile, each of the first and second shapes being configured suchthat they are indicative of a particular orientation of the orifice to aviewer while under radiographic observation.
 5. The method of claim 1,wherein the leaflet structure is attached to a support structure.
 6. Themethod of claim 5, wherein each of the first and second imageableelements is attached to the support structure.
 7. The method of claim 5,wherein each of the first and second imageable elements comprises acannula attached to the support structure.
 8. The method of claim 5,wherein each of the first and second imageable elements comprises alayer of material disposed on the support structure.
 9. The method ofclaim 5, wherein the support structure comprises a plurality of struts,and wherein each of the first and second imageable elements comprisesone or more struts of the plurality of struts configured to comprise aradiographic profile that is visually distinct from other struts of theplurality of struts.
 10. The method of claim 5, wherein the valveprosthesis further comprises a covering material attached to the supportstructure and enclosing one of the first and second imageable elements.11. The method of claim 5, wherein the support structure comprises aframe having first and second coiled bends and wherein each of the firstand second imageable elements comprises a radiopaque element disposedwithin one of the first and second coiled bends.